NDC 68726-900 Pigment

Hydroquinone

NDC Product Code 68726-900

NDC 68726-900-31

Package Description: 7.4 mL in 1 BOTTLE, PLASTIC

NDC 68726-900-32

Package Description: 1 BOTTLE, PUMP in 1 BOX > 29.5 mL in 1 BOTTLE, PUMP

NDC Product Information

Pigment with NDC 68726-900 is a a human over the counter drug product labeled by Physicians Care Alliance, Llc (d/b/a Pca Skin). The generic name of Pigment is hydroquinone. The product's dosage form is gel and is administered via topical form.

Labeler Name: Physicians Care Alliance, Llc (d/b/a Pca Skin)

Dosage Form: Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Pigment Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • HYDROQUINONE 2 g/100mL

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • WATER (UNII: 059QF0KO0R)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
  • ALCOHOL (UNII: 3K9958V90M)
  • LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)
  • AZELAIC ACID (UNII: F2VW3D43YT)
  • KOJIC ACID (UNII: 6K23F1TT52)
  • HAMAMELIS VIRGINIANA TOP WATER (UNII: NT00Y05A2V)
  • HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)
  • PHENYLETHYL RESORCINOL (UNII: G37UFG162O)
  • BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
  • GLUTATHIONE (UNII: GAN16C9B8O)
  • MILK THISTLE (UNII: U946SH95EE)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Physicians Care Alliance, Llc (d/b/a Pca Skin)
Labeler Code: 68726
FDA Application Number: part358A What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 05-26-2011 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

End Marketing Date: 01-15-2022 What is the End Marketing Date?
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Pigment Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Other

Drug Facts

Active Ingredient

Hydroquinone (2%)

Purpose

Skin lightener

Uses

For gradual fading of discolorations of the skin such as freckles, age and liver spots, pigment in the skin that may occur from pregnancy or the use of oral contraceptives.

Warnings

For external use only

When Using This Product

  • Avoid contact with the eyesSome users of this product may experience a mild skin irritationDo not use on children under 12 years of age unless directed by a physician

Otc - Stop Use

Stop use and consult a physician if skin irritation becomes severe.

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Adults: Apply a small amount as a thin layer on the affected area twice daily or use as directed by a physicianIf no improvement is seen after 3 months of treatment, use of this product should be discontinuedLightening effect of this product may not be noticeable when used on very dark skinSun exposure should be limited by using a sunscreen agent or protective clothing when using or after using this product in order to prevent darkening from reoccurring

Other Information

Store at room temperature (15-30 °C / 59-86 ° F).

Inactive Ingredients

Water/Aqua/Eau, Alcohol, Butylene Glycol, Hamamelis Virginiana (Witch Hazel) Water, Lactic Acid, Azelaic Acid, Kojic Acid, Phenylethyl Resorcinol, Hydroxyethylcellulose, Sodium Hydroxide, BHT, Glutathione, Silybum Marianum Fruit Extract.

* Please review the disclaimer below.